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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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INSTI HIV-1/HIV-2 Antibody Test - 00686597010198

Single-use rapid assay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and Type 2 (HIV-1, HIV-2)
Biolytical Laboratories Inc
90-1019
In Commercial Distribution

  • 00686597010198 ()
90-1019

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Geenius - 03610520013847

Geenius HIV 1/2 Supplemental assay
BIO-RAD
72461
In Commercial Distribution

  • 03610520013847 ()
72461

  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

3 x 4% E-Gel 48 Gels - 10888234500667

For Use with ThromboType1
IMMUCOR GTI DIAGNOSTICS, INC.
EGEL48
In Commercial Distribution

  • 10888234500667 ()
EGEL48

  • Multiple human platelet antigen (HPA) typing IVD, kit, multiplex

ThromboType® - 10888234500285

ThromboType assay is an assay for the molecular determination of HPA-1 (PlA), HPA-2 (Ko), HPA-3 (Bak), HPA-4 (Pen), HPA-5 (Br), HPA-6 (Ca), and HPA-15 (Gov), using PCR amplification of human genomic DNA.
IMMUCOR GTI DIAGNOSTICS, INC.
THROMBOTYPE
Not in Commercial Distribution

  • 10888234500285 ()
THROMBOTYPE

  • Multiple human platelet antigen (HPA) typing IVD, kit, multiplex

ThromboType®1 - 10888234500261

ThromboType 1 assay is an assay for the molecular determination of HPA-1 (PlA) using PCR amplification of human genomic DNA.
IMMUCOR GTI DIAGNOSTICS, INC.
THROMBOTYPE1
In Commercial Distribution

  • 10888234500261 ()
THROMBOTYPE1

  • Multiple human platelet antigen (HPA) typing IVD, kit, multiplex

Negative Control Serum - 10888234400622

For Use with LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
403887
Not in Commercial Distribution

  • 10888234400622 ()
403887

  • HLA class II antigen tissue typing IVD, kit, multiplex

Positive Control Serum - 10888234400615

For Use with LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
403892
Not in Commercial Distribution

  • 10888234400615 ()
403892

  • HLA class II antigen tissue typing IVD, kit, multiplex

Negative Control Serum - 10888234400592

For Use with LIFECODES Class I ID
IMMUCOR GTI DIAGNOSTICS, INC.
628209
Not in Commercial Distribution

  • 10888234400592 ()
628209

  • HLA class I antigen tissue typing IVD, kit, multiplex

Positive Control Serum - 10888234400585

For Use with LIFECODES Class I ID
IMMUCOR GTI DIAGNOSTICS, INC.
628208
Not in Commercial Distribution

  • 10888234400585 ()
628208

  • HLA class I antigen tissue typing IVD, kit, multiplex

LIFECODES Wash Buffer - 10888234400578

For Use with LIFECODES Class I ID and LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
628221
Not in Commercial Distribution

  • 10888234400578 ()
628221

  • HLA class I antigen tissue typing IVD, kit, multiplex
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